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GLS-5310 Vaccine for the Prevention of SARS-CoV-2 (COVID-19)

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ClinicalTrials.gov Identifier: NCT04673149
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
GeneOne Life Science, Inc.

Brief Summary:
This clinical trial will evaluate the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2(COVID-19) in healthy volunteers.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Biological: GLS-5310 Biological: Placebo Phase 1 Phase 2

Detailed Description:

This Phase I / IIa study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine.

The Phase I portion of this study is an open-label, dose escalation study to assess two dose levels of GLS-5310 DNA vaccine (0.6 and 1.2 mg) as part of two vaccination regimens (0-8 weeks and 0-12 weeks).

The Phase IIa portion of this study is designed as a randomized, double-blind, placebo-controlled study with only a single active study drug arm. Subjects will be randomized to receive either placebo or GLS-5310 vaccine in a 1:2 ratio.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Multicenter, Randomized, Combined Phase I Dose-escalation and Phase IIa Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Immunogenicity of GLS-5310 DNA Vaccine, Administered Intradermally Against SARS-CoV-2 in Healthy Adults
Actual Study Start Date : December 23, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: GLS-5310 0.6mg [Group 1a]
0.6mg of GLS-5310 will be intradermally administered on Day 0 and Week 8.
Biological: GLS-5310
GLS-5310 DNA plasmid vaccine

Experimental: GLS-5310 1.2mg [Group 1b]
1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8.
Biological: GLS-5310
GLS-5310 DNA plasmid vaccine

Experimental: GLS-5310 1.2mg [Group 1c]
1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 12.
Biological: GLS-5310
GLS-5310 DNA plasmid vaccine

Placebo Comparator: Placebo [Group 2a]
Placebo will be intradermally administered on Day 0 and Week 8 (or Week 12).
Biological: Placebo
Placebo

Experimental: GLS-5310 1.2mg [Group 2b]
1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8 (or Week 12).
Biological: GLS-5310
GLS-5310 DNA plasmid vaccine




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Through 48 weeks post vaccination ]
    solicited/unsolicited local and systemic AEs after vaccination

  2. Geometric mean titer (GMT) of antigen-specific binding antibody titers [ Time Frame: Through 48 weeks post vaccination ]
    Endpoint titer of binding antibody in serum


Secondary Outcome Measures :
  1. Evaluation of positive response rate of T cell responses induced by GLS-5310 DNA vaccine [ Time Frame: Through 48 weeks post vaccination ]
    T-cell response of antigen-specific interferon - gamma (IFN-γ) secretion in PBMC at each timepoint

  2. Geometric mean titer (GMT) of neutralizing antibody titers [ Time Frame: Through 48 weeks post vaccination ]
    Plaque-reduction neutralizing titer(PRNT) in serum at each timepoint


Other Outcome Measures:
  1. Determine IgG antibody responses after a single dose of vaccine related to treatment arm [ Time Frame: Through 1 year post vaccination ]
    Endpoint titer of binding antibody in serum at each timepoint

  2. Measure survival rate of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2. [ Time Frame: Through 1 year post vaccination ]
    Survival rate

  3. Persistence of immune responses following vaccination with GLS-5310 [ Time Frame: Through 1 year post vaccination ]

    Endpoint titer of binding antibody in serum at each timepoint

    • Plaque-reduction neutralizing titer in serum at each timepoint
    • T-cell response of antigen-specific interferon - gamma (IFN-γ) secretion in PBMC at each timepoint

  4. Determine the extent of immune boosting for participants who are seropositive at baseline following vaccination with GLS-5310 [ Time Frame: Through 1 year post vaccination ]

    Change from baseline in binding antibody titers

    • Change from baseline in T-cell response of antigen-specific interferon - gamma (IFN-γ)
    • Change from baseline in plaque-reduction neutralizing titer(PRNT) in serum

  5. Measure viral load in organs, including blood, of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2. [ Time Frame: Through 1 year post vaccination ]
    viral load measurement of blood and major organs

  6. Perform histologic examination of organs of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2. [ Time Frame: Through 1 year post vaccination ]
    pathological examination of organs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 19 to 65 years of age (Phase I will be restricted to an upper age limit of 50 years of age)
  2. Able to provide informed consent
  3. Able and willing to comply with study procedures
  4. For women of childbearing potential, able and willing to use an approved form of pregnancy prevention through to 4 weeks post boost vaccination

Exclusion Criteria:

  1. Current or planned pregnancy through to 4 weeks post-boost vaccination for women of childbearing potential
  2. Currently breastfeeding
  3. Current or past participation in a coronavirus (MERS-CoV, SARS-CoV-2) vaccine study
  4. Administration of an investigational agent within 6 months of the 1st dose
  5. Administration of a vaccine within 4 weeks prior to the 1st dose
  6. Administration of immune globulin within 16 weeks of enrollment
  7. Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or anti-CD20 monoclonal antibody rituximab within 24 weeks prior to enrollment
  8. Current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater, dexamethasone of 3 mg or greater; or the equivalent dose of other systemic corticosteroids
  9. Administration of any Immunosuppressive Drug or Immunomodulator within 3 months of the first dose
  10. History of bone marrow transplantation
  11. Current or planned chemotherapy treatment for hematologic or solid tumor during study period or treatment during the 5 years prior to enrollment
  12. Respiratory disease (ex. Asthma, Chronic obstructive lung disease)
  13. Cardiovascular disease (ex. myocardial ischemia, congestive heart failure, cardiomyopathy, clinically significant arrhythmia)
  14. Hypertension (Systolic pressure >150mmHg or Diastolic pressure >95mmHg)
  15. Confirmed Diabetes
  16. Severe allergic reaction or anaphylactic reaction after vaccination in the past
  17. Immunosuppresion including immunodeficiency disease or family history
  18. Positive of serum test at screening (Hepatitis B, Hepatitis A, HIV, Hepatitis C)
  19. Baseline screening lab(s) with Non Clinical Significant abnormality
  20. Serious adverse reaction to a drug containing Investigational Product (GLS-5310) or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history
  21. History of hypersensitivity to vaccination such as Guillain-Barre syndrome
  22. History of PCR-confirmed infection with SARS-CoV-2 at screening
  23. Subjects who have been contact with COVID-19 infections in the past prior to administration, have been classified as COVID-19 confirmed patients, medical patients or patients with symptoms or have been identified with SARS and MERS infection history in the past
  24. 37.5 degrees, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration
  25. Healthcare workers participating in the medical examination of patients infected with COVID-19
  26. Not willing to allow storage and future use of samples for SARS-CoV-2 related research
  27. Prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness
  28. Any illness or condition that, in the opinion of the investigator, may affect the safety of the subject or the evaluation of a study endpoint

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673149


Contacts
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Contact: Joel N Maslow, MD. Ph.D. +1-610-707-5671 jmaslow@geneonels-us.com
Contact: Hyojin Lee, M.S. +82-2-6004-3468 hjlee@genels.com

Locations
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Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 08308
Contact: Woo Joo Kim, MD, Ph.D.    +82-2-2626-1114    wjkim@korea.ac.kr   
Sponsors and Collaborators
GeneOne Life Science, Inc.
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Responsible Party: GeneOne Life Science, Inc.
ClinicalTrials.gov Identifier: NCT04673149    
Other Study ID Numbers: CoV2-001
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GeneOne Life Science, Inc.:
COVID-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases